Stryker Receives FDA Warning Letter
Stryker Corporation (NYSE: SYK)
announced today that its Instruments division has received a warning letter
from the U.S. Food and Drug Administration (FDA) related to observations made
during a November 2012 inspection at its Portage, Michigan location.
The letter concerns quality system observations made during the inspection and
cites Stryker for failing to notify the FDA of a product recall, and for
marketing devices, including the Neptune Waste Management System, without a
required 510(k) clearance. The letter acknowledged that Stryker Instruments
has already submitted corrective action plans for the quality system and
recall observations. The Company is fully cooperating with the FDA to resolve
these matters in a comprehensive and timely manner.
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